Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of Anticoagulant-related Nephropathy in the Cohort
研究概览
简要总结
Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners which leads to kidney dysfunction. A recent review suggests that kidney function should be assessed (by measuring serum creatinine) serially in the first few months of starting a blood thinner. ARN is diagnosed when there is a decline in kidney function after starting the blood thinner and other possible causes of this decline have been excluded. ARN has mainly been studied in relation to the common blood thinner - warfarin, where the prevalence is variable but can be as high as 37% (approximately 1 in 3) in the patients at highest risk. The risk factors that make this side effect more likely include the presence of pre-existing kidney disease, high blood pressure, older age and diabetes mellitus. Studies have shown that the occurence of ARN can lead to an accelerated progression of pre-existing kidney disease and a 65% increase in the risk of death (mortality).
The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been recently approved for use as blood thinners. They have a faster onset of action compared to warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case reports that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is no study that has determined the true incidence of ARN in NOACs. Our study is designed to find out the incidence of ARN in patients who are started on rivaroxaban.
The investigators intend to serially monitor the kidney function of 40 high risk patients who are recently started on rivaroxaban over a six month period. This will enable us to discover how many patients actually develop ARN after starting a NOAC. The information the investigators will obtain from this study will enable patients and health care providers make better decisions about using blood thinners. If the investigators find that the incidence of ARN with rivaroxaban is less common than that previously reported with warfarin, it can potentially make more patients use the NOACs and hence save them from the morbidity and mortality associated with ARN. Our study is unique because this will be the first study focused on ARN in one of the new blood thinners. The information the investigators get from this study will be a very important foundation for future studies.
详细描述
Anticoagulation-related nephropathy (ARN) is an understudied renal complication of anticoagulant therapy that is characterized by acute kidney injury (AKI) defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL, without any alternate etiology, in the setting of a supra-therapeutic International Normalized Ratio (INR) greater than 3.0 [1-7]. ARN has mainly been studied in relation to warfarin, it usually occurs in the first two months of starting anticoagulant therapy and retrospective studies have estimated the prevalence to range from 16% to 37% [4-6]. The strongest risk factor for ARN is pre-existing chronic kidney disease (CKD); other risk factors include older age, diabetes mellitus and hypertension [1,4]. Patients with ARN have an accelerated progression of CKD and a retrospective study of more than 15,000 patients on warfarin showed a 65% increase in mortality in patients with ARN [4,6].
The non-vitamin K oral anticoagulants (NOACs) are replacing warfarin in the clinical setting for long term anticoagulation because of the advantages of faster, reliable onset of action, and unlike warfarin, they do not require dose-response monitoring [8-10]. Rivaroxaban is the most commonly prescribed NOAC at Einstein Medical Center Philadelphia. A few animal models and case reports have shown that these NOACs (particularly dabigatran and apixaban) can lead to deterioration of kidney function, but there is limited epidemiologic data on ARN in NOACs and the incidence of ARN in NOACs is unknown [11-14]. A proposed guideline to diagnose ARN recommends that serum creatinine and urinalysis be checked monthly in the first few months of anticoagulation [1]. Clinical trials that compared warfarin to NOACs specifically studied stroke risk and bleeding outcomes and did not document the incidence of ARN because they did not make these regular creatinine and urinalysis measurements in the first few months of anticoagulation [15-20]. Our study intends to make these necessary measurements in a selected group of high risk patients started on rivaroxaban and hence determine the incidence of ARN in this group.
This study will be the first epidemiological study using a prospective design to measure the incidence of ARN in a population receiving NOACs. Given the high morbidity and mortality associated with ARN, the findings will enhance patient safety, enabling patients and health providers to make informed decisions with their patients regarding the choice of anticoagulants. It will also establish baseline data that will serve as foundation for future studies.
The specific aims of this study will be to -
- Determine the incidence of ARN in high risk patients on rivaroxaban. Hypothesis - the incidence of ARN in rivaroxaban is less than the previously reported incidence of ARN in warfarin.
- Describe demographic and urinalysis-associated predictors of ARN in patients on rivaroxaban.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •GFR ≤ 60 ml/L based on creatinine clearance
- •Participant has been initiated on long term anticoagulation with rivaroxaban for atrial fibrillation within four weeks of recruitment
排除标准
- •History of blood dyscrasias or active bleeding,
- •History of hematuria
- •Patients on dialysis
结局指标
主要结局
Incidence of Anticoagulant-related Nephropathy in the Cohort
时间窗: 6 months
Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage.
次要结局
未报告次要终点
研究者
Basma Abdulhadi
Medical Resident
Albert Einstein Healthcare Network